Orthopedic care for animals has become a pivotal aspect of veterinary medicine, especially in managing fractures, joint disorders, and various musculoskeletal issues (1,3,5,6,20,24). As the companion animal sector in South Korea grows, so does the demand for sophisticated veterinary orthopedic products. The development and deployment of these products are essential not only for quality care but also for advancing veterinary surgical practices.

Orthopedic surgeries in veterinary clinics mainly involve knee surgeries, fracture repairs, and spinal procedures (5,6,8,13,16,21). Veterinary hospitals in South Korea employ a broad array of orthopedic products, including bone plates, screws, bone cement, and external fixation devices. These products play a critical role in the successful treatment of varied orthopedic conditions, ensuring stability and aiding the healing process of bones and joints in animals (6,18).

However, the use of orthopedic materials for veterinary purposes in South Korea presents several challenges. A significant issue is the dependence on human orthopedic products due to the lack of viable animal-specific alternatives. This reliance raises concerns regarding the suitability, safety, and effectiveness of these products in veterinary applications (11,12). Moreover, veterinary hospitals encounter difficulties due to a limited variety of available orthopedic products, insufficient product information, and the absence of clear standards for animal-specific orthopedic devices (11,12).

This study aims to examine the current status of the domestic market for veterinary orthopedic products in South Korea and assess their usage in animal hospitals. By surveying both veterinary clinics and suppliers of orthopedic products, the research seeks to gain insights into the types of orthopedic surgeries most commonly performed, the products most frequently used, and the challenges faced by both consumers (veterinary hospitals) and suppliers (manufacturers and importers). Additionally, this research explores the potential need for developing new standards and specifications for animal orthopedic products to ensure their safety, effectiveness, and quality.

Ultimately, this research aims to enhance the veterinary orthopedic market in South Korea by supporting the development of superior, more specialized orthopedic products for animals and ensuring that veterinary hospitals have access to high-quality and reliable materials for treating musculoskeletal conditions. The findings of this study are anticipated to serve as a foundation for future advancements in product development, regulatory frameworks, and the overall quality of veterinary orthopedic care.

Survey

To investigate the current status of use, supply, and manufacturing standards of orthopedic products used in veterinary hospitals in Korea, a survey was conducted from September 1 to September 30, 2020. The survey was completed both online and offline. At the beginning of the survey, participants were informed that their participation was voluntary and anonymous, that their responses would be processed and analyzed post-survey, and they expressed their consent to participate by clicking on the web link for the survey. No medical information was collected. Data was collected and analyzed anonymously, with no written consent obtained. No compensation or rewards were provided for participation.

Consumer (veterinarian)

The survey was conducted among 320 animal hospitals that advertise orthopedic surgeries online, out of approximately 3,260 registered with the Korean Veterinary Medical Association. It was directed to the chief veterinarians of these hospitals. The survey was distributed both online and offline. For the offline survey, a questionnaire was mailed to the 320 clinics, representing 7%, and their participation was encouraged through phone calls while also providing information about the online survey on Google. In total, 153 clinics (47%), including 33 offline and 120 online participants, responded as indicated in Table 1. The survey covered the following topics: 1. Classification of hospital location (metropolitan area, metropolitan city, local area). 2. Classification hospital grade (primary, secondary, tertiary hospital). 3. Types of orthopedic surgery, 4. Orthopedic products in use, 5. Use of and reasons for adopting human orthopedic products, 6. Reference values for animals using human orthopedic products, 7. Accessibility of purchasing animal orthopedic products, and 8. Orthopedic supplies needing replenishment.

Table 1 . Survey response statistics of veterinary hospitals performing orthopedic surgery among 3,260 companion animal hospitals in Korea.

Parameters	No. of clinics (%)
Veterinary hospitals performing orthopedic surgeries	320 (9.8)
Veterinary hospitals responding to the survey	153 (47.8)

Supplier (manufacturer and importer)

The supplier survey targeted companies licensed or applying to produce and supply veterinary clinics with orthopedic products. An online survey via Google targeted 29 suppliers, including manufacturers and importers of these products. Of these, 14 companies responded. The survey included: 1. Types of orthopedic supplies provided (manufactured, imported, human, veterinary), and 2. Safety assessments of the orthopedic supplies (imported, human).

Statistical analysis

Cronbach’s alpha was estimated to assess the reliability of the survey questionnaire calculated. A Cronbach’s alpha value exceeding 0.7 was considered indicative of acceptable internal consistency. Various frequency analysis were performed to overview multivariable distribution of the responses. Statistical tests such as analysis of variance (ANOVA), and chi-square test were conducted to evaluate significance of the associations between variables. All statistical analyses were conducted using R version 4.3.1 (R Core Team, Vienna, Austria), at a significance level of 0.05.

Consumer (animal hospital)

Classification of orthopedic surgery practices in animal hospitals

Among the 153 responding hospitals, 115 were primary care institutions performing small-scale orthopedic surgeries, accounting for 75.2%. Additionally, 36 hospitals were secondary care institutions with at least three veterinarians, comprising 23.5%. It was noted that 140 of the 153 hospitals (90.7%) perform orthopedic surgeries.

The results of investigating the surgery types according to the grade of animal hospitals for the six surgical items that frequently use orthopedic products showed that ligament surgery, femoral head removal, pelvic surgery, and spinal surgery were performed at a higher rate in hospitals of secondary or higher grade (p < 0.05). In addition, knee surgery was a surgery that was commonly performed regardless of the grade of the hospital. This result indicates that as the grade of the hospital increases, more complex and difficult surgeries are performed than general orthopedic surgeries (Table 2).

Table 2 . Relationship between types of orthopedic surgery and veterinary hospital grade in 140 animal hospitals performing orthopedic surgery.

Surgery types	Percentage of veterinary hospital grade (mean ± SD)			p-value
	Primary	Secondary	Tertiary
Knee	39.22 ± 23.5	32.92 ± 15.8	27.50 ± 10.6	0.102
Ligament	11.30 ± 10.2a	16.94 ± 8.3b	15.00 ± 7.1b	0.005
Femoral head removal	18.35 ± 13.6a	12.92 ± 5.7a	12.50 ± 10.6a	0.021
Fracture	12.90 ± 12.8	14.17 ± 6.9	27.50 ± 10.6	0.217
Pelvic	5.31 ± 7.4b	8.61 ± 4.9a	5.00 ± 7.1b	0.033
Spine	0.61 ± 2.0a	7.22 ± 5.4b	2.50 ± 3.5c	<0.001
Others	2.74 ± 10.4	4.31 ± 3.8	7.50 ± 3.5	0.227

There is a significant difference between the parameters within rows (a, b, c)..

Orthopedic products used in veterinary hospitals

To examine the utilization of orthopedic products in veterinary hospitals, researchers surveyed 17 types of these products. The results revealed that splints were the most frequently used (104/140, 74.3%), followed by fracture fixation plates (93/140, 66.4%), reusable external fixation devices (93/140, 66.4%), surgical drills (93/140, 66.4%), fracture fixation screws (92/140, 65.7%), medical chisels (89/140, 63.6%), bone forceps (87/140, 62.1%), orthopedic plates (85/140, 60.7%), and metal bone fixation materials (57/140, 40.7%). Veterinary hospitals typically regard fracture fixation plates and fracture fixation screws as fundamental and indispensable products (Fig. 1).

Figure 1. The orthopedic equipment used by 113 animal hospitals performing orthopedic surgeries.

As a result of investigating the usage rate of orthopedic products by region (metropolitan area, metropolitan city, local area) of animal hospitals, it was confirmed that the usage rate of orthopedic templates, orthopedic fixation stapler, and bone lever significantly increased from local areas to metropolitan areas (p < 0.05) (Table 3).

Table 3 . Usage rates of orthopedic products by veterinary hospital location.

Orthopedic products	Metropolitan area (%)	Metropolitan city (%)	Local area (%)	p-value
Orthopedic bone plate	32.0	28.8	17.0	0.338
Orthopedic bone screw	31.4	27.5	17.6	0.527
Orthopedic bone screw, biodegradable	10.5	11.8	5.2	0.571
Orthopedic external fixation system	20.9	15.7	10.5	0.368
Orthopedic bone wire	33.3	28.1	18.3	0.263
Reusable external fixation device	13.1	7.2	7.2	0.199
Disposable external fixation device	11.8	9.8	9.2	0.496
Splint	35.3	32.7	20.3	0.513
Intramedullary pin	28.1	28.8	15.7	0.424
Bone cement	19.0	11.8	9.2	0.148
Bone holding forceps	29.4	27.5	18.3	0.946
Orthopedic hand drill	32.7	28.8	19.6	0.584
Orthopedic chisel	32.0	28.1	17.6	0.444
Periosteum removal	31.4	24.2	17.6	0.136
Orthopedic template	15.0a	6.5b	6.5b	0.036
Orthopedic fixation stapler	9.2a	3.9b	1.3b	0.026
Bone lever	15.0a	6.5b	7.2b	0.038
Others	10.5	5.9	5.2	0.333

There is a significant difference between the parameters within rows (a, b)..

Current status of use of orthopedic products for human use

According to the survey results, 65 out of 140 veterinary hospitals (46.4%) were using orthopedic devices for animals, whereas 85 hospitals (60.7%) were not. Despite fewer hospitals using these devices compared to those that do not, a significant number of veterinary hospitals continue to utilize them, indicating a substantial demand for orthopedic devices in veterinary practice. Hospitals cited the following reasons for using human orthopedic devices for animals (Table 4): 58 hospitals used them due to the absence of suitable animal-specific alternatives; 21 chose them for their cost-effectiveness compared to animal orthopedic products; 17 reported superior performance to animal-specific devices; and another 17 hospitals used them based on recommendations or prior experience. The predominant reason cited for using orthopedic devices was the lack of alternative animal-specific products.

Table 4 . Reasons for using human orthopedic products in veterinary hospital.

Reasons	No. of animal hospital
No alternative orthopedic products for animals	58
Cheaper than orthopedic products for animals	21
Better performance compared to orthopedic products for animals	17
Recommendations or previous experience using it	17
During equipment setting process	1

When asked about the inconvenience caused by the lack of reference values for animal orthopedic devices when using human orthopedic products in veterinary medicine, 93 out of 144 veterinary hospitals reported difficulties, while 51 did not experience such issues. This highlights the need for establishing reference values for the use of human orthopedic products in animals.

The survey reveals that the usage of human orthopedic products in veterinary practices is hindered by a lack of reference data for animals, leading to inconvenience. Of the 140 animal hospitals surveyed, 93 encountered this issue, while 51 did not. It is, therefore, necessary to provide animal-specific reference measurements when using human orthopedic products in veterinary care, underscoring the importance of tailored data to assist veterinarians in making precise diagnoses and treatments (Table 5).

Table 5 . Necessity of providing information on effectiveness, suitability or safety in animals when using human orthopedic products for animals.

Answer	No. of animal hospital
Really	51
Yes	60
No need	18
Not necessary at all	1
Never thought	16

Difficulties in purchasing or using orthopedic products for animals

The survey results on the difficulties in purchasing and using orthopedic products for animals identified the most common issue as a limited variety of animal orthopedic products (19 responses), followed by inadequate product information at the point of sale (14 responses), declining product quality (11 responses), and insufficient information about product availability (8 responses). Only one instance mentioned the absence of animal-specific features (Table 6).

Table 6 . Inconveniences when purchasing and using orthopedic products for animals.

Inconveniences	No. of animal hospital
Lack of product variety	19
Lack of information about the product	14
Deterioration of product quality	11
Lack of information about product purchase	8
The product price is expensive	5
Lack of compatibility between products	2
Lack of animal specificity	1
Others	5

Orthopedic products that veterinarians would like to apply in future treatments

The survey on orthopedic products veterinarians intend to use in future treatments indicated that fracture fixation plates were the most requested (14 responses). These plates vary depending on the animal's size or weight, yet access to them is limited in animal hospitals. A significant number of hospitals also showed interest in resorbable fracture fixation plates. The next most popular item was artificial joints (9 responses), suggesting an advancement in surgical techniques and increased owner awareness, leading to more complex surgeries. Other mentioned products were fracture fixation screws (7 responses), artificial patellar grooves (4 responses), and external fixation devices (3 responses). These findings reflect a demand for more specialized and advanced orthopedic products to address the increasing complexity of veterinary surgeries and improve treatment options for animals (Table 7).

Table 7 . Orthopedic products to apply in *future treatments.

Orthopedic product	No. of responses
Fracture fixation plates (resorbable, interlocking)	14
Artificial joints (customized for patients)	9
TPLO set	8
Fracture fixation screws (resorbable)	7
Artificial trochlear groove	4
External fixation devices (reusable)	3
Bone grafting material	2
Fracture fixation wire	2
Metal bone fixation devices (with screw holes)	2
3D-printed customized implants	1
Fiber wire (Tiger wire)	1
Maxillofacial plate & screw	1
Suture anchor	1
Fracture fixation wire	1
Fracture fixation bond	1
Bone stapler	1
Spinal fixation implant	1

*Orthopedic products that are not currently in use but that you would like to use in the future if you have the chance..

Supplier (manufacturer and importer)

The supply types of orthopedic products

In a survey concerning the supply methods of orthopedic products, either through direct manufacturing or importation, results indicated that of 15 companies, six manufacture and supply over 90% of their products. Conversely, four companies import and supply more than 90% of their products. Three companies exclusively rely on imports, while one manufactures 100% of its products. The remaining 10 companies utilize a mix of manufacturing and importing, with proportions varying by product (Fig. 2).

Figure 2. Supply types of orthopedic supplies based on manufacturing and importing.

The orthopedic products supplied by manufacturers and importers

In the survey on the types of orthopedic products being manufactured and imported, 11 companies were found to supply fracture fixation screws, ten supply fracture fixation plates, 6 supply bone cement, and four supply metal bone fixation devices. These companies primarily supply products frequently used in veterinary hospitals (Fig. 3).

Figure 3. The supply ratio of human and veterinary orthopedic supplies.

Supply ratio of orthopedic products for human use

A survey among suppliers about the sources of orthopedic products revealed that eight companies provide orthopedic products for human use and ten for animals. Of these, four companies supply over 90% of their products for humans, while seven solely focus on animal orthopedic products. The remaining four companies offer a combination of both, showcasing a versatile supply chain. This structure highlights the specialization of some companies in either human or animal products, while others serve both markets (Fig. 4).

Figure 4. Whether safety evaluation is conducted for manufactured or imported orthopedic supplies.

Orthopedic products supplied to veterinary hospitals

A survey on the types of orthopedic products being manufactured and imported found that 11 companies supply fracture fixation screws, ten companies supply fracture fixation plates. Additionally, six companies supply bone cement, and four supply metal bone fixation devices. The survey indicates that suppliers primarily cater to products commonly used in veterinary hospitals, as these orthopedic items are essential for treating fractures and other conditions in animals (Table 8).

Table 8 . Status of supply of orthopedic products to animal hospitals.

Orthopedic products	No. of supplier
Fracture joint screw	11
Fracture joint plate	10
Bone cement	6
Special material fracture joint screw	5
Intramedullary fixation rod	5
Metal frame fixing material	4
Fracture bonding wire	4
Reusable external fixation device	3
Orthopedic template	2
Fracture joint staple	2
Disposable external fixation device	2

Evaluation of the safety of orthopedic products for animals

In response to inquiries about safety evaluations or internal testing by manufacturers or importers of orthopedic products, seven suppliers confirmed that they conduct safety evaluations or internal testing. Conversely, four suppliers reported that they do not perform these evaluations or tests. This indicates a variation in safety management among suppliers, underscoring the importance of standardized evaluation procedures to ensure product quality and safety (Fig. 5).

Figure 5. The number of suppliers providing human orthopedic supplies to animal hospitals.

Safety assessment of orthopedic devices for use in animals

Regarding the inquiry about whether suppliers perform efficacy or safety testing on animals before distributing human orthopedic products to veterinary hospitals, four out of eight suppliers confirmed conducting such tests. Meanwhile, three suppliers admitted they do not perform these tests. This situation reveals that while some suppliers verify their products' efficacy and safety through testing, others do not, before supplying them to veterinary hospitals (Fig. 6).

Figure 6. Whether safety testing on animals is conducted prior to sale when supplying human orthopedic supplies to animal hospital.

This study aimed to investigate the current status of veterinary orthopedic product usage and supply in South Korea and to identify challenges faced by veterinary hospitals and suppliers. The findings offer valuable insights into the veterinary orthopedic product market, highlight key issues, and propose potential enhancements for developing more specialized and effective orthopedic products for animals.

The most commonly used orthopedic products in veterinary hospitals were splints, fracture fixation plates, external fixation devices, surgical drills, and fracture fixation screws (5,18). These products are crucial for treating fractures and other prevalent orthopedic conditions. Notably, nearly all surveyed veterinary hospitals considered fracture fixation plates and screws to be fundamental and essential (11,12). The survey results revealed that most veterinary hospitals (90.7%) perform orthopedic surgeries, with knee surgeries being the most frequent. This suggests that fracture treatment is the most common orthopedic procedure in veterinary practices, highlighting the critical importance of these products for successful clinical outcomes (9,20). However, many veterinary hospitals continue to rely on human orthopedic products due to a scarcity of specialized animal orthopedic devices. The primary reasons for using human orthopedic products include the absence of animal-specific alternatives, cost-effectiveness, and perceived superior performance (4,10). This reliance demonstrates a market gap for animal-specific orthopedic solutions and emphasizes the necessity for continued research and development of veterinary orthopedic devices tailored to the anatomy and needs of animals (12,14,15,20).

According to the survey, 42.5% of veterinary hospitals utilize human orthopedic devices due to the unavailability of suitable animal-specific products, their cost-effectiveness, and perceived superior performance. However, a prominent issue noted by 93 out of 144 hospitals was the absence of reference values specific to animals when employing human orthopedic products. These products, not specifically designed for animals, may lead to potential complications (11,12). This underscores the challenges veterinarians encounter in providing accurate diagnoses and making precise treatment decisions due to the lack of animal-specific data (6). Consequently, there is an urgent need for the development of reference values and guidelines tailored for animals to ensure safe and effective use of human orthopedic products in veterinary medicine. This necessitates the establishment of animal-specific safety standards and the compilation of extensive data to aid veterinarians in using human products effectively and safely in treating animals (25).

The survey of suppliers indicated that the majority of companies concentrate on manufacturing and supplying fracture fixation screws, plates, bone cement, and other commonly utilized orthopedic products for veterinary hospitals. Some suppliers also import human orthopedic products for veterinary use, highlighting the scarcity of animal-specific alternatives in the market (11). This dependence on human products underscores the necessity for innovation and enhancement in the orthopedic device supply specifically designed for veterinary use. Furthermore, the study revealed that seven suppliers conduct internal safety evaluations and testing on their products, whereas four do not. This inconsistency in safety management highlights the need for more standardized safety protocols to ensure the quality and reliability of veterinary orthopedic products (1).

The study also explored the supply chain dynamics of orthopedic products for veterinary use. It revealed that while some suppliers manufacture most of their products, others heavily rely on imports. Some companies exclusively import products, whereas others focus on manufacturing, with many engaging in a combination of both manufacturing and importing depending on the specific product. Although the supply chain is diverse, the survey underscored a significant issue: the lack of consistent safety evaluation processes among suppliers. Seven out of the 15 companies surveyed conduct safety evaluations or internal testing, while four do not. This variation in safety assessment practices highlights the need for more standardized safety protocols across the industry to ensure the reliability and safety of the products provided to veterinary hospitals (2,7,23). Moreover, the absence of safety and efficacy testing for some products, particularly those intended for human use but adapted for veterinary applications, presents significant risks. Four out of eight suppliers who provide human orthopedic products for animals reported that they conduct safety and efficacy testing, while three do not. This inconsistency underlines the importance of implementing robust testing procedures to ensure the safety of veterinary products, whether they are originally designed for human use or specifically for animals (7,23).

In the United States, the Foods and Veterinary Medicine division operates under the Food and Drug Administration. Within this framework, the Center for Veterinary Medicine (CVM) is responsible for managing both veterinary medical devices and veterinary drugs. However, the CVM does not have separate ratings, reporting systems, or licensing regulations specifically for veterinary medical devices. Instead, manufacturers and sellers of veterinary medical devices must adhere to regulations ensuring the safety and appropriate labeling of their products. Additionally, the CVM maintains a database containing information on all veterinary medical device-related products, providing convenience to consumers and suppliers by integrating relevant data (18). In Europe, the EudraVigilance Veterinary system operates to collect and organize information regarding veterinary side effects. This system not only notifies users and regional authorities of adverse events online but also facilitates the proactive sharing of information about side effects occurring outside the European Union (7,17,18). In Korea, the Ministry of Food and Drug Safety (MFDS) focuses on ensuring the quality control of human medical devices in compliance with international standards. The MFDS also contributes to the domestic medical device industry's development by supporting approvals, examinations, and quality control through the establishment and revision of standards aligned with the latest international guidelines. On the other hand, the Animal and Plant Quarantine Agency oversees the quality control of veterinary medical devices. While it provides some information for consumers and suppliers, this area is still in its initial development stages (11).

Recommendations for improving orthopedic products for animals include: Firstly, there is a clear demand for the development of animal-specific orthopedic products. Many veterinary hospitals have expressed interest in advanced products such as resorbable fracture fixation plates, artificial joints, and specialized fracture fixation screws. These products are crucial for addressing the growing complexity of orthopedic surgeries in animals and increasing awareness among pet owners about advanced treatments (22). Research and development efforts should target creating products that meet the unique needs of animals, ensuring compatibility with their anatomical and physiological characteristics (16). Secondly, the safety and efficacy of veterinary orthopedic products must be prioritized. Although some suppliers perform safety evaluations, many do not, introducing potential risks for animals. To mitigate this, consistent and rigorous testing should be mandatory for all orthopedic products, regardless of whether they are specifically designed for animals or adapted from human use (12). Third, veterinary hospitals encounter challenges related to the purchasing process, mainly due to the lack of product variety and inadequate product information. Suppliers should strive to provide clear, comprehensive information about their products and enhance accessibility to a broader range of orthopedic materials (5). Furthermore, pricing strategies should be adjusted to make these products more affordable for veterinary practices, which often operate under budget constraints (19).

This study has highlighted key issues in the South Korean veterinary orthopedic market such as reliance on human orthopedic products, lack of animal-specific options, and challenges in product safety and availability. Addressing these issues will necessitate concerted efforts from the veterinary industry, suppliers, and regulatory bodies to develop safer, more effective, and specialized orthopedic products for animals. The findings underline the necessity for innovation, standardized safety testing, and improved accessibility to enhance the quality of veterinary orthopedic care in South Korea. Ultimately, these improvements will contribute to more effective treatments for animals, supporting their health and well-being.

This study was conducted with a grant from the Animal and Plant Quarantine Agency technology development project in 2020 (Improvement of Standard and Specification, and Reevaluation of Orthopedic Materials for Veterinary Use; Z-1543072-2020-21-0101).

The authors have no conflicting interests.